Combined cryotherapy and hypothermia method for the treatment of airway obstruction or prostate enlargement

ABSTRACT

A method of reducing tissue volume for treatment of airway obstruction, obstructive sleep apnea, snoring, prostate tumor, and other pathologies comprising: applying a cryoprobe with a diameter preferably less than about 2 mm and with a sharp tip to first freeze the affected interstitial tissue of the soft palate, base of the tongue, tonsils or adenoids, singularly or in combination, or to the prostate, or other tissue, and then applying the same cryoprobe to heat the treated tissue.

FIELD AND BACKGROUND OF THE INVENTION

[0001] The present invention relates to a method of reducing tissuevolume by applying a unique cryoprobe. The invention is especiallyuseful in reducing pharyngeal tissues, including tonsils and softpalate, in treating upper airway obstruction, such as exists inobstructive sleep apnea, and or snoring, or in treating an enlargedprostate, and is described below with respect to such applications, butit will be appreciated that the invention could advantageously be usedin other applications as well, such as, in treating abundant vasculartissue in the uterus, as found in menometrorrhagia, or in treatinghypertrophic inferior turbinates in nasal obstruction.

[0002] Obstructive Sleep Apnea is of unknown etiology, but it isgenerally accepted that it results from the combination of astructurally small upper airway and a normal or abnormal loss ofphysiologic muscle tone during sleep. Patterns of pharyngeal narrowingand collapse suggest that 30-50% of patients with obstructive sleepapnea have obstruction at the level of the upper pharynx or in theretropalatal segment. This can be due to abundant tissue of the palateor tonsillar hypertrophy. An even higher percentage of snorers have thesoft palate as the source of the vibrations of snoring.

[0003] Obstructive Sleep Apnea is a potentially life threateningdisorder, which affects up to 2 to 4% of the adult population. Even whennot life threatening, it is annoying to a bed mate. Obstructive SleepApnea is associated with snoring, which is believed to affect 20% ofadults.

[0004] In the past, surgical treatments have been used to treatObstructive Sleep Apnea. One treatment is by a surgical operationinvolving removal of the tonsils and soft palate (uvulopharyngealpalatoplasty). Another surgical treatment involves midline glossectomy.These surgical procedures often occur with general anesthesia,postoperative pain, bleeding risks, substantial recovery times andhospitalization. Recently, more minimal procedures have been introducedincluding laser resection and radio frequency volumetric reduction ofthe soft tissue palate.

OBJECTS AND BRIEF SUMMARY OF THE INVENTION

[0005] An object of the present invention is to provide a method ofreducing tissue, which is particularly useful for treating tissueobstructions and enlargements, such as occurring in obstructive sleepapnea, by using a cryoprobe to first freeze and then sequentially heatthe tissue. This invention has the advantage of being a minimallyinvasive procedure.

[0006] Another object of the present invention is to provide a method ofreducing tissue with minimal bleeding, by using a cryoprobe to firstfreeze and ablate the tissue and then using the same or a differentcryoprobe to heat and further ablate the tissue and to coagulate bloodvessels. This invention also has the advantage of reducing oreliminating bleeding by coagulation resulting from thermoablation.

[0007] A further object of the present invention is to provide a methodof reducing tissue by initially quickly freezing the tissue to reduceand locally destroy tissue and then heating the tissue to further reducethe tissue and to prevent or minimize bleeding. This method prevents orminimizes damage to mucous membranes and reduces pain and scarring.

[0008] According to the present invention, there is provided a method ofreducing tissue, comprising: first applying a cryoprobe with a diameterpreferably less than 2 mm and with a sharp tip to freeze the affectedinterstitial tissue of the soft palate, base of the tongue, tonsils oradenoids, singularly or in combination, and then applying a probe,preferably the same cryoprobe to heat to coagulate and/or ablate thetreated tissue.

[0009] In one and the preferred described embodiment, interstitialablation of the soft palate is performed by applying a cryoprobe withdiameter preferably less than 2 mm and with a sharp tip to initiallyfreeze the affected interstitial tissue of the soft palate, and thenapplying the same cryoprobe to heat the treated tissue to achievefurther tissue removal, to achieve easier probe removal, to avoidsticking of tissue to the frozen probe surface and to coagulate thesuperficial vascular tissue surrounding the probe insertion site.

[0010] In a second described embodiment, interstitial ablation of thesoft palate, base of the tongue, tonsils and/or adenoids is performed byapplying a cryoprobe with a diameter preferably less than 2 mm and witha sharp tip to initially freeze the affected interstitial tissue, and,then, applying the same cryoprobe to heat the treated tissue to achievefurther tissue removal, to achieve easier probe removal, to avoidsticking of tissue to the frozen probe surface and to coagulate thesuperficial vascular tissue surrounding the probe insertion site.

[0011] In a third embodiment, interstitial ablation of the soft palate,base of the tongue, tonsils and/or adenoids is performed by firstapplying a cryoprobe with a diameter preferably less than 2 mm and witha sharp tip to heat the affected interstitial tissue, and then applyingthe same cryoprobe to freeze the treated tissue to achieve furthertissue removal.

[0012] In yet another embodiment, interstitial ablation of the softpalate, base of the tongue, tonsils and/or adenoids is performed byapplying a cryoprobe with a diameter preferably less than 2 mm and witha sharp tip to only freeze the affected interstitial tissue.

[0013] In another embodiment, interstitial ablation of the soft palate,base of the tongue, tonsils and/or adenoids is performed by applying acryoprobe with diameter preferably less than 2 mm and with a sharp tipto only heat the affected interstitial tissue.

[0014] In another embodiment, interstitial ablation of the ovo-pharynxis performed by applying a cryoprobe with a diameter preferably lessthan 2 mm and with a sharp tip to freeze the affected interstitialtissue.

[0015] In another embodiment, interstitial ablation of the ovo-pharynxis performed by applying a cryoprobe with a diameter preferably lessthan 2 mm and with a sharp tip to heat the affected interstitial tissue.

[0016] In another embodiment, interstitial ablation of the inferiorturbinates of the nose is performed to relieve nasal obstruction byapplying a cryoprobe with a diameter preferably less than 2 mm and witha sharp tip to initially freeze the affected interstitial tissue of theinferior turbinates and then applying the same cryoprobe to heat thetreated tissue to achieve further tissue removal of the affected tissue.This is intended to relieve nasal obstruction.

[0017] In another embodiment, interstitial ablation of the prostate isperformed by applying a cryoprobe with a diameter preferably less than 2mm and with a sharp tip to initially freeze the affected interstitialtissue of the prostate, and applying the same cryoprobe to then heat thetreated tissue to achieve further tissue removal, to achieve easierprobe removal, to avoid sticking of tissue to the frozen probe surfaceand to coagulate the superficial vascular tissue surrounding the probeinsertion site. The invention also contemplates applying a flexiblecryoprobe of the described type for use in conjunction with acystoscope.

[0018] In another embodiment, a thermoregulator is used to control thetemperature of application of the cryoprobe.

[0019] The described methods of reducing tissue may also be used inother applications, for example, and not by limitation, in the medicaltreatment of menometrorrhagia.

[0020] Further features and advantages of the invention will be apparentfrom the description below.

BRIEF DESCRIPTION OF THE DRAWINGS

[0021] The invention is described, by way of example only, withreference to the accompanying drawings, where:

[0022]FIG. 1 is a front perspective view of a patient's mouth andillustrates one form of the method of reducing tissue, as applied to thesoft palate in accordance with the present invention.

DETAILED DESCRIPTION OF THE DRAWINGS AND THE PREFERRED EMBODIMENTS

[0023] The method of reducing tissue, as illustrated in FIG. 1,comprises applying a cryoprobe, generally designated 1, with a diameter2 (preferably less than 2 mm) and with a sharp tip 3, to initiallyfreeze the affected interstitial tissue of the soft palate 4, and then,by applying the same cryoprobe to heat the treated tissue to achievefurther tissue removal, to achieve easier probe removal, to avoidsticking of tissue to the frozen probe surface and to coagulate thesuperficial vascular tissue surrounding the probe insertion site.

[0024]FIG. 2 illustrates a variation of the basic and preferred methodin which the cryoprobe 5 is flexible and used with a cystoscope 6.

[0025] While the invention has been described and illustrated in detailwith respect to two particular applications, it will be appreciated thatthe described method of reducing tissue may be used in a wide variety ofother medical applications, e.g., for treatment of menometrorrhagia; byreversing the steps so as to first heat and then freeze, by using thecryoprobe to freeze and then heat the endometrium of the uterus; by onlyheating or only freezing tissue, etc.

[0026] Many other variations and applications of the invention will beapparent to those of ordinary skill in the art.

We claim:
 1. A method of reducing tissue, comprising: freezinginterstitial ovopharyngeal tissue with a cryoprobe.
 2. A method ofreducing tissue, comprising: heating interstitial ovopharyngeal tissuewith a cryoprobe.
 3. A method for reducing tissue, comprising: freezingand heating said tissue with the same cryoprobe.
 4. A method fortreatment of snoring, comprising: freezing interstitial tissue of thesoft palate or tonsils with a cryoprobe.
 5. A method for treatment ofsnoring, comprising: heating interstitial tissue of the soft palate ortonsils with a cryoprobe.
 6. A method for treatment of snoring,comprising: a) using a cryoprobe to first freeze at least one section ofthe patient selected from the group comprising: the base of the tongue;the soft palate; and/or the tonsils; and b) then heating said part ofthe patient with said cryoprobe.
 7. A method for treatment of snoring,comprising: a) first freezing with a cryoprobe at least two sections ofthe patient selected from the group comprising: the tonsils, the softpalate; the base of the tongue; and b) then heating the selectedsections with a cryoprobe.
 8. A method for treatment of tonsillarenlargement, comprising: a) first freezing the tonsils with a cryoprobe;and b) then heating the tonsils with a cryoprobe.
 9. A method fortreatment of snoring, comprising: freezing with a cryoprobe at least onesection of the patient selected from the group comprising: the softpalate; the tonsils; and the base of the tongue.
 10. A method fortreatment of Obstructive Sleep Apnea, comprising: a) first freezing atleast one section of the patient selected from the group comprising: thesoft palate, the base of the tongue and the tonsils with a cryoprobe;and b) then heating the sections with a cryoprobe.
 11. A method fortreatment of nasal obstruction comprising: a) first freezing theinferior turbinates with a cryoprobe; and b) then heating the inferiorturbinates with a cryoprobe.
 12. A method for treatment of prostateenlargement comprising: a) first freezing the interstitial tissue of theprostate with a cryoprobe; and b) then heating the interstitial tissueof the prostate with a cryoprobe.
 13. A method for reducing body tissuewith minimal blood loss comprising: a) freezing the treated body tissuewith a cryoprobe; and b) heating the treated tissue with a cryoprobe.14. A method for reducing body tissue with minimal blood loss comprisingthe sequential steps of: a) freezing the treated body tissue with acryoprobe; and b) then heating the treated tissue with a cryoprobe. 15.The methods as claimed in claim 12 wherein only a single cryoprobe isused.
 16. The methods as claimed in claim 13 wherein only a singlecryoprobe is used.
 17. The methods as claimed in claim 14 wherein only asingle cryoprobe is used.